Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
NCT ID:
NCT00632203
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00632203
Study Brief:
Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Temozolomide Treatment | Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first. | None | None | 8 | 26 | 25 | 26 | View |
| Observation | Observation | None | None | 4 | 27 | 24 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.1 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.1 | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| STAPHYLOCOCCAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| COGNITIVE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| HEMIPARESIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| MEMORY IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |